MAUDE Adverse Event Report: SYNTHES GMBH 2.8MM DRILL BIT/QC/165MM

Catalog Number 310.284

Device Problem Failure to Cut (2587)

Patient Problem Insufficient Information (4580)

Event Date 11/23/2023

Event Type  malfunction  

Event Description

Device report from synthes reports an event in colombia as follows: it was reported that on (b)(6) 2023, the handpiece currently works by pressing the forward button; the batteries were changed to verify if it was due to battery charge, but the failure continued.Additionally, the drill bit had no cutting edge.No further information is available.This report involves one 2.8mm drill bit/qc/165mm.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E1: initial reporter facility phone number reported as: (b)(6).H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The initial complaint was reviewed and the 2.8mm drill bit/qc/165mm was found to be not reportable as this event was determined to be a duplicate of (b)(4).The 2.8mm drill bit/qc/165mm was already reported in (b)(4).

• Brand Name: 2.8MM DRILL BIT/QC/165MM
• Type of Device: DRILL BIT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18397074
• MDR Text Key: 331682921
• Report Number: 8030965-2023-16154
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819245891
• UDI-Public: (01)07611819245891
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310.284
• Device Lot Number: 46P8633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1